The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502
compared to AzaSiteŽ alone, Dexamethasone alone, and vehicle in the treatment of subjects
with Non-bacterial Blepharitis.
Inclusion Criteria:
- Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
- Signature of the subject or legally authorized representative on the Informed Consent
Form.
- Are willing and able to follow all instructions and attend all study visits.
- Are willing to avoid disallowed medication for the duration of the study.
- If female is of childbearing potential, agree to and submit a urine sample for
pregnancy testing. Post menopausal is defined as having no menses for at least 12
consecutive months.
- Additional inclusion criteria also apply.
Exclusion Criteria:
- Have known sensitivity or poor tolerance to any component of the Investigational
Drug.
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular
inflammation other than Blepharitis in the study eye.
- Have used topical corticosteroid medications or topical ophthalmic solutions that the
investigator feels may interfere with the study parameters.
- Have used any non-diagnostic topical ophthalmic solutions in the study eye.
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a
positive urine pregnancy test.
- Currently suffer from alcohol and/or drug abuse.
- Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an
investigational drug or device.
- Have a condition or a situation which, in the Investigator's opinion, may put the
subject at increased risk, confound study data, or interfere significantly with the
subject's study participation.
- Additional exclusion criteria also apply.
Arizona Eye Center, Chandler, Arizona, United States
Arizona Center for Clinical Trials LLC, Phoenix, Arizona, United States
Cornea Consultants of Arizona, Phoenix, Arizona, United States
Lugene Eye Institute, Glendale, California, United States
United Medical Research Institute, Inglewood, California 90301, United States
Macy Eye Center, Los Angeles, California 90048, United States
North Valley Eye Medical Group, Inc., Mission Hills, California, United States
Eye Research Foundation, Newport Beach, California, United States
North Bay Associates, Inc., Petaluma, California, United States
Martel Eye Medical Group, Rancho Cordova, California 95670, United States
Shasta Eye Medical Group, Inc., Redding, California, United States
San Diego Eye and Laser Center, San Diego, California 92123, United States
West Coast Eye Care Associates, San Diego, California, United States
Florida Eye Microsurgicial Institute, Inc., Boynton Beach, Florida, United States
ZASA Clinical Research, LLC, Boynton Beach, Florida, United States
Magruder Eye Institute, Orlando, Florida, United States
Vision Eye Care Center, Palm Springs, Florida, United States
International Research Center, Tampa, Florida, United States
Richard Eiferman, MD, Louisville, Kentucky, United States
Lakeview Optical, Gretna, Louisiana, United States
Center for Sight, Inc., Fall River, Massachusetts 02720, United States
Tauber Eye Center, Kansas City, Missouri, United States
Ophthalmology Associates, St. Louis, Missouri, United States
Comprehensive Eye Care Ltd, Washington, Missouri, United States
Abrams Eye Institute, Las Vegas, Nevada, United States
Nevada Eye Care Professionals, Las Vegas, Nevada, United States
Eye Care Associates of Nevada, Sparks, Nevada, United States
David Ringel, OD PA, Sewell, New Jersey, United States
Ophthalmic Consultants of Long Island, Lynbrook, New York, United States
Ophthalmic Consultants of Long Island, Rockville Centre, New York, United States
Ophthalmic Consultants of Long Island, Valley Stream, New York, United States
South Shore Eye Care, Wantagh, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A., Charlotte, North Carolina, United States
Mundorf Eye Center, Charlotte, North Carolina, United States
James Branch, MD, Winston-Salem, North Carolina, United States
Eye Care Associates of Greater Cincinnati, Inc., Cincinnati, Ohio, United States
Eye Care Associates of Greater Cincinnati, Inc., Fairfield, Ohio, United States
Eye Care Associates of Greater Cincinnati, Inc., Madeira, Ohio, United States
Roseburg Research Associates, LLC, Roseburg, Oregon 97471, United States
Philadelphia Eye Associates, Philadelphia, Pennsylvania, United States
Research Across America @ Wyomissing Optometric Center Inc, Wyomissing, Pennsylvania, United States
Total Eye Care, PA, Memphis, Tennessee, United States
David Shulman, MD, San Antonio, Texas, United States
Sun Research Institute, San Antonio, Texas, United States
Daynes Eye and Lasik, Salt Lake City, Utah 84103, United States
